Cereal extract concentration 1
OtherCereal extract will be given to see the effect on penetration and aspiration in patients with dysphagia problem
NCT Number: NCT02522351
The aim of the trial is to identify any systematic effect of cohesiveness on the efficacy of swallowing in patients having dysphagia problems.
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Notify Me18 year–85 year
All sexes
Interventional
Not applicable
Grand hopital de Charleroi, Charleroi, Belgium
This trial will be a double blind, randomized, crossover, controlled, and interventional trial. Each subject will test 6 study samples in a randomized order at 5 mL of volume first then at 10 mL (12 samples maximum). The trial will last a maximum of one hour (a single study visit).
The total sample size is 47 enrolled subjects, 33 subjects completed. Patients will be females and males aged between 18 and 85 years with mild proven dysphagia.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Cereal extract will be given to see the effect on penetration and aspiration in patients with dysphagia problem
Cereal extract will be given to see the effect on penetration and aspiration in patients with dysphagia problem
Cereal extract will be given to see the effect on penetration and aspiration in patients with dysphagia problem
Thicken up clear will be given to see the effect on penetration and aspiration in patients with dysphagia problem
Thicken up clear will be given to see the effect on penetration and aspiration in patients with dysphagia problem
Thicken up clear will be given to see the effect on penetration and aspiration in patients with dysphagia problem
Time frame: During the ingestion (videofluoroscopy), maximum during one hour.
The PAS score across each bolus (5 mL and 10 mL)
Time frame: During the ingestion (videofluoroscopy), maximum during one hour.
The prevalence of penetration in the population according to Rosenbek's PAS (score of 2-5) assessed using videofluoroscopy
Time frame: During the ingestion (videofluoroscopy), maximum during one hour.
The prevalence of aspiration in the population according to Rosenbek's PAS (score of 6-8) assessed using videofluoroscopy
Time frame: During the ingestion (videofluoroscopy), maximum during one hour.
The amount/volume of oral and pharyngeal residues assessed using videofluoroscopy
Time frame: During the ingestion (videofluoroscopy), maximum during one hour.
The prevalence of subjects of oral and pharyngeal residues assessed using videofluoroscopy
Time frame: During the ingestion (videofluoroscopy), maximum during one hour.
Oral transit time (OTT, time between tongue tip elevation and arrival of the bolus at the ramus of the mandible)
Time frame: During the ingestion (videofluoroscopy), maximum during one hour.
Swallow response time (SRT, time between arrival of the bolus at the ramus of the mandible and pharyngeal phases of swallowing)
Time frame: During the ingestion (videofluoroscopy), maximum during one hour.
Pharyngeal transit time (PTT, time between arrival of the bolus at the ramus of the mandible and the tail of the bolus passing through the upper esophageal sphincter)
Time frame: During the ingestion (videofluoroscopy), maximum during one hour.
Time to upper esophageal sphincter opening (UESO, time between tongue tip elevation and opening of the upper esophageal sphincter)
Time frame: During the ingestion (videofluoroscopy), maximum during one hour.
Time to laryngeal vestibule opening (LVO, time between tongue tip elevation and pharyngeal phases of swallowing)
Time frame: During the ingestion (videofluoroscopy), maximum during one hour.
Time to laryngeal vestibule closure (LVC, time between tongue tip elevation and maximal laryngeal closure)
Time frame: Right after ingredient ingestion, maximum during one hour.
This will be assessed from a questionnaire.
Société des Produits Nestlé (SPN)
Industry
Reduction of Aspiration Through Cohesive Thin Liquids (CTL) in Patients With Mild Oropharyngeal Dysphagia Due to Ischemic/Hemorrhagic Cerebral Cause (Stroke)
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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